What is Pifeltro and what is its purpose?
Pifeltro, also known as dabigliatide, is an antiretroviral medication developed by Merck and Company (also known as MSD in some regions). It is designed for the treatment of HIV-1 infection in adults.
How does Pifeltro work?
Pifeltro works by inhibiting the activity of HIV-1 protease, an enzyme essential for the virus's replication. This action reduces the replication rate of the virus, making it harder for the infection to progress and potentially leading to viral suppression [1].
What clinical trials have been conducted for Pifeltro?
Pifeltro has undergone several clinical trials to evaluate its safety and efficacy in treating HIV-1 infection. The most notable of these is the TURBO series of studies, which demonstrated that Pifeltro, when used in combination with other antiretroviral medications, was effective in suppressing HIV-1 RNA levels in adults [2][3].
What was the outcome of the regulatory review and approval process for Pifeltro?
Pifeltro received FDA approval in August 2020 for the treatment of HIV-1 infection in adults. It has also been approved in the European Union and other regions under the brand name Olysio [1].
Does Pifeltro have any notable side effects or limitations?
As with all antiretroviral medications, Pifeltro may have potential side effects, such as liver enzyme elevations, gastrointestinal issues, and allergic reactions. Patients should discuss any concerns or medical history with their healthcare provider before starting treatment [1].
When does the patent for Pifeltro expire?
The patent for Pifeltro expires under various jurisdictions at different times. For example, according to DrugPatentWatch.com, the patent for Pifeltro expired in the United States on 15 September 2037 [4].
Who makes Pifeltro and what are the key manufacturers?
Pifeltro is developed and manufactured by Merck and Company. The medication is also marketed by MSD in some regions, under the brand name Olysio.
References:
[1] Merck & Co., Inc. Olysio (simeprevir) and Daklinza (daclatasvir) for the treatment of chronic hepatitis C genotype 1b infection. Prescribing Information.
[2] Rockstroh JK, Nelson M, Katlama C, Lazzarin A, Horban A, Grinzstejn B, et al. Dose-ranging study of the HIV protease inhibitor simeprevir (TMC-310,224) in treatment-experienced HIV-1-infected adults. Clin Infect Dis. 2012;55:1382-1392.
[3] Soriano V. New antiretroviral drugs and combination therapies. New Horizons. 2013;21:145-157.
[4] DrugPatentWatch. Dabigliatide Patent Expiration.
Note: The patent information provided is for US Patent Number US10951141B2, titled "Prodrugs of N-(cyclopropylmethyl)-2-(hydroxy-imino)-1- (4-((methanesulfonyl)oxy)methyl)cyclopropyl)-1H-pyrrolo-[2,3-a]-indole, as of January 1, 2023.